Bharat Biotech Signs U.S. Partner for India-Approved COVID-19 Vaccine

The COVID-19 vaccine Covaxin, which was approved for emergency use in India ahead of late-stage trial results, may be coming to the U.S., as its manufacturer, Bharat Biotech, has secured a U.S. partner and plans to seek Emergency Use Authorization (EUA) from the FDA for distribution in the U.S.

Malvern, Pa.-based Ocugen will co-develop, supply and commercialize Covaxin for the U.S. market, the companies announced yesterday. The vaccine, which is currently in a phase 3 clinical trial in India, produced an enhanced immune response in an early trial. More than 13,000 volunteers out of 25,800 total participants in the phase 3 trial have received a second dose of the two-dose regimen.

Covaxin’s advantages include not needing ultra-cold storage — it can be held at standard refrigeration temperatures of 35.6 to 46.4 Fahrenheit — as well as offering “long-term persistence of immune responses to multiple viral proteins,” according to Ocugen CEO Shankar Musunuri.

Ocugen will have the U.S. rights to the vaccine candidate and will receive 45 percent of any future profits. It will also lead the clinical development, regulatory approval and commercialization in the U.S., while Bharat Biotech will ship an initial supply to the U.S. after the FDA grants an EUA.

The companies did not disclose the anticipated number of doses in the initial supply. Ocugen said it is talking to manufacturers in the U.S. about producing “a significant number” of doses. — Martin Berman-Gorvine